Politics of European scientific work and research into newborn drugs: current problems, future prospects and new opportunities
Opportunities to use the vast majority of drugs in newborns are limited, since assessing the efficacy and safety of drugs in newborns is a much more complex process than in older children and the adults. This leads to the frequent use of off-label drugs, i.e. according to indications that are not included in the official instructions for the drug, or the use of the drug in categories of patients for whom the use of this drug is not allowed (for example, in children under a certain age or the elderly), or outside the recommended dose range or frequency of administration / administration of the drug , or the use of a route of administration not regulated by the instruction.
Undoubtedly, there are diseases specific to the neonatal period, an important point is the morpho-functional immaturity, one cannot ignore the rapid development of the child in the first days and weeks of life. In connection with the above, in children, the effects of the use of a certain drug may manifest immediately or be delayed, including impaired development of the child.
To improve this situation, American and European regulators (the US Food and Drug Administration - FDA and the European Medicines Assessment Agency - EMEA) have introduced regulations on the use of medicines in pediatrics and have developed recommendations for optimizing the assessment of drug use. funds in the population of children, including the population of newborns. These joint projects are funded by the EU in cooperation with the Seventh European Framework Program (FP7), which is the main EU financial instrument to support international cooperation in research activities in almost all scientific fields.
Premature and full-term infants are very susceptible to infectious diseases that lead to increased morbidity and mortality. The objective of two projects TINN (Treat Infections in Neonates) and TINN2 was to assess the off-label use of anti-infective chemotherapy drugs included in the list of priority drugs of the EMEA - azithromycin (TINN2 project) and ciprofloxacin / fluconazole (TINN project). The final objective of these two projects is to obtain the official status of “Pediatric Use Marketing Authorization”, which legalizes the use of these drugs in new- born.
In addition, as part of the TINN project, a network of institutions and departments with experience in the evaluation of anti-infective drugs in newborns will be created. And another project, called Global Research in Pediatrics (GRIP), will focus on teaching clinical pharmacology in pediatrics and will promote the development of pediatric clinical pharmacology as well as the safe use of drugs in children.